KOATE-DVI FOR INJECTION 500 iu5 ml

Country: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

ANTIHEMOPHILIC FACTOR (HUMAN) (FACTOR VIII)

Fáanlegur frá:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC númer:

B02BD02

Skammtar:

min 400 iu/5 ml

Lyfjaform:

INJECTION, POWDER, FOR SOLUTION

Samsetning:

ANTIHEMOPHILIC FACTOR (HUMAN) (FACTOR VIII) min 400 iu/5 ml

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

Prescription Only

Framleitt af:

LUITPOLD PHARMACEUTICALS INC (Diluent Manufacturer)

Leyfisstaða:

ACTIVE

Leyfisdagur:

2002-01-24

Upplýsingar fylgiseðill

ANTIHEMOPHILIC FACTOR (HUMAN) 
1 
KOĀTE
®
-DVI 
2 
DOUBLE VIRAL INACTIVATION 
3 
SOLVENT/DETERGENT TREATED AND HEATED IN FINAL CONTAINER AT 80°C 
4 
DESCRIPTION 
5 
Antihemophilic Factor (Human), Koāte
®
-DVI, is a sterile, stable, purified, dried concentrate 
6 
of human Antihemophilic
Factor (AHF, Factor VIII) which has been treated with tri-n-butyl 
7 
phosphate (TNBP) and polysorbate 80 and heated in lyophilized
form in the final container at 
8 
80°C for 72 hours. Koāte-DVI is intended for use in
therapy of classical hemophilia 
9 
(hemophilia A). 
10 
Koāte-DVI is purified from the cold insoluble fraction
of pooled fresh-frozen plasma by 
11 
modification and refinements of the methods first described
by Hershgold, Pool, and 
12 
Pappenhagen.( [/sg_wm_2229.html#9]
1 [/sg_wm_2229.html#9]
)
[/sg_wm_2229.html#9] Koāte-DVI contains purified and concentrated Factor VIII. The Factor VIII 
13 
is 300–1000 times purified over whole plasma.
Part of the fractionation may be performed by 
14 
another licensed manufacturer. When reconstituted
as directed, Koāte-DVI contains 
15 
approximately 50–150 times as much Factor VIII as an
equal volume of fresh plasma. The 
16 
specific activity, after addition of Albumin (Human), is in the range of 9–22 IU/mg protein. 
17 
KOĀTE-DVI MUST BE ADMINISTERED BY THE INTRAVENOUS ROUTE. 
18 
Each bottle of Koāte-DVI contains the labeled
amount of antihemophilic factor activity in 
19 
international units (IU). One IU, as defined by the World
Health Organization standard for 
20 
blood coagulation Factor VIII, human, is approximately equal to
the level of Factor VIII 
21 
found in 1.0 mL of fresh pooled human plasma.
The final product when reconstituted as 
22 
directed contains not more than (NMT) 1500
μg/mL polyethylene glycol (PEG), NMT 0.05 
23 
M glycine, NMT 25 μg/mL�

Vara einkenni

DESCRIPTION
Antihemophilic Factor (Human), Ko¯
atew-DVI, is a sterile, stable, purified, dried concentrate of human
Antihemophilic Factor (AHF, Factor VIII) which
has been treated with tri-n-butyl phosphate (TNBP) and polysorbate 80
and heated in lyophilized form in the final container at 80°C for 72
hours.
Ko¯
ate-DVI is intended for use in therapy of classical hemophilia
(hemophilia A).
Ko¯
ate-DVI is purified from the cold insoluble fraction of pooled
fresh-frozen plasma by modification and refinements of the methods
first described
by Hershgold, Pool, and Pappenhagen.(1) Ko¯
ate-DVI contains purified and concentrated Factor VIII. The Factor
VIII is 300–1000 times purified over
whole plasma. Part of the fractionation may be performed by another
licensed manufacturer. When reconstituted as directed, Ko¯
ate-DVI contains
approximately 50–150 times as much Factor VIII as an equal volume of
fresh plasma. The specific activity, after addition of Albumin
(Human), is
in the range of 9–22 IU/mg protein. KO¯
ATE-DVI MUST BE ADMINISTERED BY THE INTRAVENOUS ROUTE.
Ko¯
ate-DVI contains antihemophilic factor activity in international units
(IU). One IU, as defined by the World Health Organization standard for
blood
coagulation Factor VIII, human, is approximately equal to the level of
Factor VIII found in 1.0 mL of fresh pooled human plasma. The final
product
when reconstituted as directed contains not more than (NMT) 1500
µg/mL polyethylene glycol (PEG), NMT 0.05 M glycine, NMT 25 µg/mL
polysorbate 80, NMT 5 µg/g tri-n-butyl phosphate (TNBP), NMT 3 mM
calcium, NMT 1 µg/mL aluminum, NMT 0.06 M histidine, and NMT 10 mg/mL
Albumin (Human).
CLINICAL PHARMACOLOGY
Hemophilia A is a hereditary bleeding disorder characterized by
deficient coagulant activity of the specific plasma protein clotting
factor, Factor VIII.
In afflicted individuals, hemorrhages may occur spontaneously or after
only minor trauma. Surgery on such individuals is not feasible without
first
correcting the clotting abnormality. The administr